Macular Edema
Conditions
Keywords
autologous plasmin, macular edema, vitreous
Brief summary
The purpose of this study is to evaluate in a prospective study the efficacy of intravitreal autologous plasmin enzyme in macular edema and to analyze the fibrinolytic system in vitreous body.
Detailed description
Autologous plasmin enzyme has been used to liquefy the gel structure of the vitreous body and to decrease the adherence of the posterior vitreous cortex to the inner limiting membrane in clinical studies. The investigators performed intravitreal autologous plasmin enzyme for macular edema. in addition, the investigators collected vitreous body in macular edema and analyzed fibrinolytic system.
Interventions
PROCEDUREIntravitreal injection
autologous plasmin was prepared in the operation department. Samples (3.5 mL) of autologous whole blood, collected by sterile vacuum blood collection tubes, were obtained from a peripheral vein. The blood was centrifuged at 4,000 rounds per minute for 15 minutes to obtain complete sedimentation of the cells; 1.5 mL of the plasma was aspirated and transferred under sterile conditions in a vial of urokinase(10,000 IU) that had been incubated for 15 minutes at 37°C. By gently moving the vial for 5 minutes, the solution was incubated for 15 minutes at 37°C; 0.2 mL of the obtained solution was used for intravitreal injection.
Sponsors
Hallym University
Hallym University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* eyes with macular edema * those who showed poor outcomes in visual acuity or macular thickness after grid laser,triamcinolone,or bevacizumab therapy or a combination of these treatments.
Exclusion criteria
* uncontrolled blood pressure (systolic and diastolic blood pressure greater than 150 and 90 mm Hg, respectively) * renal insufficiency * intraocular surgery or any intravitreal treatment during the previous 3 months * history of ocular hypertension and/or glaucoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central macular thickness after intravitreal autologous plasmin injection | 1 month after intervention | Central macular thickness measured by optocal coherence tompgraphy |
| Visual acuity after intravitreal autologous plasmin | 1 Month after intervention | logMAR visual acuity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fibrinolytic system | baseline | plasminogen, tissue plasminogen activetor, anti-pasminogen receptor, antithrombin |
Countries
South Korea
Contacts
Primary ContactJiWOn Lim, MDPhD
Outcome results
None listed